Job Summary: The Senior Quality Control Microbiologist ensures compliance with microbiological testing standards, supports operations through microbial monitoring, and oversees lab activities to maintain regulatory and quality requirements.
Key Responsibilities:-Oversee daily microbiology lab operations, ensuring compliance with GLP and GMP.-Conduct microbiological assays, including microbial monitoring, gram staining, and aseptic testing.-Investigate out-of-specification or out-of-trend results.-Maintain, calibrate, and troubleshoot microbiology lab equipment.-Prepare media, reagents, and samples for analysis.-Document and report test results per SOPs and regulatory guidelines.-Ensure training compliance and support continuous improvement initiatives.
Required Qualifications:
-Education: B.S. In Biology or related field.
-Liquid pharmaceuticals/liquid filling experience.
-Well versed in USP chapters 51, 61, and 62 (especially 51).
-5+ years’experience in Microbiology.
-2+ years Pharmaceutical Manufacturing Laboratory experience.
-Strong knowledge of microbiological techniques, regulatory compliance (cGMP, FDA, OSHA), and quality systems (CAPAs, deviations, change control).
-Other: Proficiency with Microsoft Office and lab-related software.
Physical Requirements:
-Ability to lift 50 lbs.
-Ability to walk, stand, or sit for extended periods.
